Lower Limb UlcersNCT06557538
A Comparison of Automatic ABPI vs Manual ABPI Device Scores
An observational study of Lower Limb Ulcers, run by University of Southampton at 1 site in United Kingdom.
Trial summary
The aim of the study is to compare the Ankle Brachial Pressure Index (ABPI) scores of two devices. The two devices that will be compared are the MESI MD ABPI automatic device and the Huntleigh Dopplex manual device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Ulcers
- What is being tested?
- Automatic Ankle Brachial Pressure Index device assessment and Manual Ankle Brachial Pressure Index assessment
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Sep 2024to 20 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with an open referral to Berkshire community services, living in the county of Berkshire with a lower limb ulcer.
Who may be able to join
- Participants over 18 years old
- Participants will have at least one lower limb ulcer
- Participants will have capacity to consent
- Participants will live in the Geographical area of Berkshire
Who cannot join
- Participants found on assessment to have monophasic pulse sounds or signs of aortic stenosis
- Patients deemed to not have capacity to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Berkshire Healthcare NHS Foundation Trust
Bracknell, Berkshire, rg12 2ut
About this study
Official title: Comparing the Ankle Brachial Pressure Index Score of Automatic ABPI Device vs Manual ABPI Device to Classify Lower Limb Ulcers and Guide Treatment in Patients Under Community Services
The aim of the study is to compare the Ankle Brachial Pressure Index (ABPI) scores of two devices. The two devices that will be compared are the MESI MD ABPI automatic device and the Huntleigh Dopplex manual device.
The Huntleigh Dopplex manual device is widely used, though the MESI MD ABPI automatic devices can reduce waiting times, reduce discomfort for patients and save nursing time. ABPI devices provide a score that supports nurses to provide suitable treatment for patients with a lower limb ulcer.
In the community, patients with lower limb ulcers are offered an ABPI assessment and then treatment is decided based on the score. Participants will be patients with lower limb ulcers referred to community nursing for a lower limb and ABPI assessment. At their routine appointment patients will have a manual assessment and an automatic assessment, and the results will be compared. The study will take place in the county of Berkshire either in patients' homes or in the lower limb clinic. Registered nurses will undertake all assessments. The direct care part of the study will run from July 2024 - December 2024. The data will be pseudonymised, and the findings written as a report that may be sent for publishing.
Read the detailed description
A lower limb ulcer is defined as a non-healing wound, venous disease being the most common cause and the gold standard treatment is compression therapy. The estimated cost implication of managing wounds in the UK is more than £5 billion per year with much of that cost coming from Nursing time and resources Wounds UK classify lower limb ulcers as either a 'Simple venous lower limb ulcer' or 'Complex venous ulcer'. National Institute for Health and Care Excellence states that lower limb ulcer assessments should be holistic including, lower limb, and wound assessments to enable early intervention, increase healing rates, and reduce financial burden. Patients should have an Ankle Brachial Pressure Index (ABPI) measurement assessment which will then give a clinical result to support classification of lower limb ulcers and to establish whether compression therapy is appropriate.
Historically, ABPI has been measured manually using a handheld doppler. This method can be time consuming, unreliable and requires a skilled clinician to undertake it. The test takes between 30 minutes to 1 hour and can also cause significant discomfort for patients with lower limb ulcers as cuffs are placed on limbs and inflated up to four times on each.
With the increasing cost and ageing population, it has been identified that healthcare professionals should be aware of advances in technology and use devices available that are more efficient, providing better patient outcomes. With that said, new automated devices have become available and have been used in community trusts since November 2022. These devices are more time efficient, user friendly and more comfortable for people with lower limb ulcers. The MESI MD ABPI device was introduced into Berkshire Healthcare NHS Foundation Trust (BHFT) in November 2022.
In 2022 NHS England (NHSE) published a Commissioning for Quality and Innovation (CQUIN) guidance with CQUIN targets aimed at ensuring robust, quality wound assessment and reducing deficiencies in intervention and care for patients with lower limb ulcers.
The NHSE CQUIN require 50% of patients with lower limb wound(s) to have a full clinical assessment within 28 days of initial wound presentation and have compression therapy of 40mmHg applied. Following the introduction of the MESI MD ABPI automatic devices to BHFT, the CQUIN achievement results increased by 10%.
Due to the impact of introducing the MESI MD ABPI device BHFT wished to continue with their use. NICE published the guidance on usage of automatic ABPI measurement devices in people with lower limb ulcers. They identified that there is a lack of evidence on the accuracy of automated ABPI devices. They provided a criterion for Trusts who want to continue using these devices. It was identified that the trust met all NICE criteria except for Criteria. Therefore, BHFT agreed to support an research study project on the MESI MD ABPI device to compare its agreement with results of the manual doppler.
As an advanced clinician expected to be competent in the four pillars of advanced practice including research, I agreed this would be an appropriate study for me to undertake as it would benefit both my development, and patients under our care.
NICE Criterion for continued use of automatic ABPI devices.
- People using the devices have experience assessing peripheral arterial disease.
- People using the devices are aware of their limitations, particularly diagnostic accuracy, and the risk of missing peripheral arterial disease, and that there are differences between devices.
- Further assessment using other methods, including manual doppler, is available.
- Trusts using devices collect data or do research to assess their value and how well they identify people with peripheral arterial disease.
NICE advised that future research on automated ABPI devices should:
- Assess their ability to detect peripheral arterial disease in people with leg ulcers
- Assess how they affect time to treatment for venous leg ulcers
- Assess clinical outcomes for treatments started after ABPI assessment
- Explore the most appropriate user (specialist and non-specialist in assessing peripheral arterial disease) and the most appropriate healthcare setting for their use
- Explore whether different ABPI thresholds can improve their sensitivity for detecting peripheral arterial disease.
There are several studies and anecdotal evidence that the automatic devices save time and reduce time to treatment in line with CQUIN standards. However, there is dearth of research on the efficacy of the automatic devices and therefore, it was decided to undertake a study on comparing the results of the automatic to the validated manual device to fulfil criteria one.
- Conditions
- Lower Limb Ulcers
- Being tested
- Automatic Ankle Brachial Pressure Index device assessment, Manual Ankle Brachial Pressure Index assessment
- Keywords
- Lower limb ulcers, Automatic ankle brachial pressure index, MESI MD ABPI, Huntleigh dopplex, Community, Comparison, ABPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic Ankle Brachial Pressure Index device assessmentDevice
The automatic device assesses 3 limbs, providing automatic simultaneous ABPI measurement of systolic, diastolic and mean arterial blood pressure on to calculate the patient\'s ABPI (Medi UK 2022).
Manual Ankle Brachial Pressure Index assessmentDevice
The manual device assesses 4 limbs, providing brachial, ankle and pedal systolic pressures. A simple calculation is then made by the clinician to determine the ratio of ankle and brachial systolic pressure (ABPI) (Day 2015).
| Study group | Role | What they receive |
|---|---|---|
| People over the age of 18 with lower limb ulcers under Community Services | Comparison of reading between automatic and manual device ABPI scores Receives: Device: Automatic Ankle Brachial Pressure Index device assessment; Device: Manual Ankle Brachial Pressure Index assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Brachial Pressure score
Difference between ABPI scores from automatic and manual ABPI device.
Measured: Through study completion of average of 7 months
Secondary outcomes (1)
Difference in lower limb ulcer classification
Difference in lower limb ulcer classification between automatic and manual ABPI device.
Measured: Through study completion of average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start16 Sep 2024
- Primary completion24 Dec 2024
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Lower Limb UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- Berkshire Healthcare NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Jamal Hossain, PHD, Study chair, School of Health Sciences,University of Southampton,Highfield Campus,University Road,Soton SO17 1BJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557538
- Sponsor's protocol ID
- ERGO 92967
- Status last verified
- Sep 2024
- First submitted
- 7 Aug 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be held in the University repository and be available for use in future study.
Publications
Al-Qaisi M, Nott DM, King DH, Kaddoura S. Ankle brachial pressure index (ABPI): An update for practitioners. Vasc Health Risk Manag. 2009;5:833-41. doi: 10.2147/vhrm.s6759. Epub 2009 Oct 12.
PubMed 19851521Boast, G., Green, J., Chambers, R. and Calderwood, R. (2019) 'Improving assessment and management of lower limb wounds', Journal of community nursing,33 (5), pp. 34 - 38
Benbow M. An introduction and guide to effective Doppler assessment. Br J Community Nurs. 2014 Dec;Suppl Wound Care:S21-6. doi: 10.12968/bjcn.2014.19.Sup3.S21.
PubMed 25478852Buxey, K. (2020) 'Introducing MESI ABPI MD automated device to a leg club setting', Journal of Community Nursing, 34 (1), pp. 22- 26
Day J. Diagnosing and managing venous leg ulcers in patients in the community. Br J Community Nurs. 2015 Dec;20 Suppl 12:S22-30. doi: 10.12968/bjcn.2015.20.Sup12.S22.
PubMed 26639070Dowsett, C. and Taylor, C. (2018) 'Reducing variation in leg ulcer assessment management using quality improvement methods', Wounds UK, 14 (4), pp. 46 - 51
Boyers, D., Cruickshank, M., Aucott, L., Kennedy, C., Manson, P., Bachoo, P. and Brazelli, M (2022) Automated measurement of ankle brachial pressure index for assessing the presence of peripheral arterial disease in people with leg ulceration, University of Aberdeen Report. Available at: diagnostics-assessment-report
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Grove, SK., Gray, JR. and Burns, N. (2019) Understanding Nursing Research: Building an Evidence-Based Practice. St. Louis, Missouri: Elsevier
Lloyd- Jones, M. (2019) 'Wound Care: What's new? 1. Ankle and brachial pressure index in practice', British journal of Healthcare Assistants, 13 (9), pp. 422- 426
Medi UK Ltd. (2022) Instructions for use: MESI ABPI MD, Ankle Brachial Pressure Index. Available at: www.mediuk.co.uk
Moffat, C., Martin, R. and Smithdale, R. (2007) Leg Ulcer Management. Oxford: Blackwell publishing
National Health Service England (NHSE) (2022) Commissioning for Quality and Innovation (CQUIN): 2023/24 guidance. Available at: https://www.england.nhs.uk/nhs-standard-contract/cquin/cquin-23-24/
Guest JF, Ayoub N, McIlwraith T, Uchegbu I, Gerrish A, Weidlich D, Vowden K, Vowden P. Health economic burden that wounds impose on the National Health Service in the UK. BMJ Open. 2015 Dec 7;5(12):e009283. doi: 10.1136/bmjopen-2015-009283.
PubMed 26644123Lindsay, E. and Whiteley, M. (2018) A partnership approach: helping patients with leg ulcers and varicose veins', Wounds UK, 14 (3), pp. 86- 88
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Ankle Brachial Pressure Index Score of Automatic ABPI Device vs Manual ABPI Device to Classify Lower Limb Ulcers and Guide Treatment in Patients Under Community Services
- ClinicalTrials.gov ID
- NCT06557538
- Acronym / sponsor ID
- ERGO 92967
- Conditions
- Lower Limb Ulcers
- Keywords
- Lower limb ulcers, Automatic ankle brachial pressure index, MESI MD ABPI, Huntleigh dopplex, Community, Comparison, ABPI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- Berkshire Healthcare NHS Foundation Trust
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare the Ankle Brachial Pressure Index (ABPI) scores of two devices. The two devices that will be compared are the MESI MD ABPI automatic device and the Huntleigh Dopplex manual device.
The Huntleigh Dopplex manual device is widely used, though the MESI MD ABPI automatic devices can reduce waiting times, reduce discomfort for patients and save nursing time. ABPI devices provide a score that supports nurses to provide suitable treatment for patients with a lower limb ulcer.
In the community, patients with lower limb ulcers are offered an ABPI assessment and then treatment is decided based on the score. Participants will be patients with lower limb ulcers referred to community nursing for a lower limb and ABPI assessment. At their routine appointment patients will have a manual assessment and an automatic assessment, and the results will be compared. The study will take place in the county of Berkshire either in patients' homes or in the lower limb clinic. Registered nurses will undertake all assessments. The direct care part of the study will run from July 2024 - December 2024. The data will be pseudonymised, and the findings written as a report that may be sent for publishing.
Detailed description
A lower limb ulcer is defined as a non-healing wound, venous disease being the most common cause and the gold standard treatment is compression therapy. The estimated cost implication of managing wounds in the UK is more than £5 billion per year with much of that cost coming from Nursing time and resources Wounds UK classify lower limb ulcers as either a 'Simple venous lower limb ulcer' or 'Complex venous ulcer'. National Institute for Health and Care Excellence states that lower limb ulcer assessments should be holistic including, lower limb, and wound assessments to enable early intervention, increase healing rates, and reduce financial burden. Patients should have an Ankle Brachial Pressure Index (ABPI) measurement assessment which will then give a clinical result to support classification of lower limb ulcers and to establish whether compression therapy is appropriate.
Historically, ABPI has been measured manually using a handheld doppler. This method can be time consuming, unreliable and requires a skilled clinician to undertake it. The test takes between 30 minutes to 1 hour and can also cause significant discomfort for patients with lower limb ulcers as cuffs are placed on limbs and inflated up to four times on each.
With the increasing cost and ageing population, it has been identified that healthcare professionals should be aware of advances in technology and use devices available that are more efficient, providing better patient outcomes. With that said, new automated devices have become available and have been used in community trusts since November 2022. These devices are more time efficient, user friendly and more comfortable for people with lower limb ulcers. The MESI MD ABPI device was introduced into Berkshire Healthcare NHS Foundation Trust (BHFT) in November 2022.
In 2022 NHS England (NHSE) published a Commissioning for Quality and Innovation (CQUIN) guidance with CQUIN targets aimed at ensuring robust, quality wound assessment and reducing deficiencies in intervention and care for patients with lower limb ulcers.
The NHSE CQUIN require 50% of patients with lower limb wound(s) to have a full clinical assessment within 28 days of initial wound presentation and have compression therapy of 40mmHg applied. Following the introduction of the MESI MD ABPI automatic devices to BHFT, the CQUIN achievement results increased by 10%.
Due to the impact of introducing the MESI MD ABPI device BHFT wished to continue with their use. NICE published the guidance on usage of automatic ABPI measurement devices in people with lower limb ulcers. They identified that there is a lack of evidence on the accuracy of automated ABPI devices. They provided a criterion for Trusts who want to continue using these devices. It was identified that the trust met all NICE criteria except for Criteria. Therefore, BHFT agreed to support an research study project on the MESI MD ABPI device to compare its agreement with results of the manual doppler.
As an advanced clinician expected to be competent in the four pillars of advanced practice including research, I agreed this would be an appropriate study for me to undertake as it would benefit both my development, and patients under our care.
NICE Criterion for continued use of automatic ABPI devices.
- People using the devices have experience assessing peripheral arterial disease.
- People using the devices are aware of their limitations, particularly diagnostic accuracy, and the risk of missing peripheral arterial disease, and that there are differences between devices.
- Further assessment using other methods, including manual doppler, is available.
- Trusts using devices collect data or do research to assess their value and how well they identify people with peripheral arterial disease.
NICE advised that future research on automated ABPI devices should:
- Assess their ability to detect peripheral arterial disease in people with leg ulcers
- Assess how they affect time to treatment for venous leg ulcers
- Assess clinical outcomes for treatments started after ABPI assessment
- Explore the most appropriate user (specialist and non-specialist in assessing peripheral arterial disease) and the most appropriate healthcare setting for their use
- Explore whether different ABPI thresholds can improve their sensitivity for detecting peripheral arterial disease.
There are several studies and anecdotal evidence that the automatic devices save time and reduce time to treatment in line with CQUIN standards. However, there is dearth of research on the efficacy of the automatic devices and therefore, it was decided to undertake a study on comparing the results of the automatic to the validated manual device to fulfil criteria one.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People over the age of 18 with lower limb ulcers under Community Services | – | Device: Automatic Ankle Brachial Pressure Index device assessment, Device: Manual Ankle Brachial Pressure Index assessmentComparison of reading between automatic and manual device ABPI scores |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with an open referral to Berkshire community services, living in the county of Berkshire with a lower limb ulcer.
Key inclusion criteria (4 listed)
- Participants over 18 years old
- Participants will have at least one lower limb ulcer
- Participants will have capacity to consent
- Participants will live in the Geographical area of Berkshire
Key exclusion criteria (2 listed)
- Participants found on assessment to have monophasic pulse sounds or signs of aortic stenosis
- Patients deemed to not have capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic Ankle Brachial Pressure Index device assessmentThe automatic device assesses 3 limbs, providing automatic simultaneous ABPI measurement of systolic, diastolic and mean arterial blood pressure on to calculate the patient\'s ABPI (Medi UK 2022). | Device | People over the age of 18 with lower limb ulcers under Community Services |
| Manual Ankle Brachial Pressure Index assessmentThe manual device assesses 4 limbs, providing brachial, ankle and pedal systolic pressures. A simple calculation is then made by the clinician to determine the ratio of ankle and brachial systolic pressure (ABPI) (Day 2015). | Device | People over the age of 18 with lower limb ulcers under Community Services |
Primary outcome
Ankle Brachial Pressure score
Time frame: Through study completion of average of 7 months
Difference between ABPI scores from automatic and manual ABPI device.
1 secondary outcome
Difference in lower limb ulcer classification
Time frame: Through study completion of average of 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 19851521Al-Qaisi M, Nott DM, King DH, Kaddoura S. Ankle brachial pressure index (ABPI): An update for practitioners. Vasc Health Risk Manag. 2009;5:833-41. doi: 10.2147/vhrm.s6759. Epub 2009 Oct 12.
- BackgroundBoast, G., Green, J., Chambers, R. and Calderwood, R. (2019) 'Improving assessment and management of lower limb wounds', Journal of community nursing,33 (5), pp. 34 - 38
- Background: PubMed 25478852Benbow M. An introduction and guide to effective Doppler assessment. Br J Community Nurs. 2014 Dec;Suppl Wound Care:S21-6. doi: 10.12968/bjcn.2014.19.Sup3.S21.
- BackgroundBuxey, K. (2020) 'Introducing MESI ABPI MD automated device to a leg club setting', Journal of Community Nursing, 34 (1), pp. 22- 26
- Background: PubMed 26639070Day J. Diagnosing and managing venous leg ulcers in patients in the community. Br J Community Nurs. 2015 Dec;20 Suppl 12:S22-30. doi: 10.12968/bjcn.2015.20.Sup12.S22.
- BackgroundDowsett, C. and Taylor, C. (2018) 'Reducing variation in leg ulcer assessment management using quality improvement methods', Wounds UK, 14 (4), pp. 46 - 51
- BackgroundBoyers, D., Cruickshank, M., Aucott, L., Kennedy, C., Manson, P., Bachoo, P. and Brazelli, M (2022) Automated measurement of ankle brachial pressure index for assessing the presence of peripheral arterial disease in people with leg ulceration, University of Aberdeen Report. Available at: diagnostics-assessment-report
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- BackgroundGrove, SK., Gray, JR. and Burns, N. (2019) Understanding Nursing Research: Building an Evidence-Based Practice. St. Louis, Missouri: Elsevier
- BackgroundLloyd- Jones, M. (2019) 'Wound Care: What's new? 1. Ankle and brachial pressure index in practice', British journal of Healthcare Assistants, 13 (9), pp. 422- 426
- BackgroundMedi UK Ltd. (2022) Instructions for use: MESI ABPI MD, Ankle Brachial Pressure Index. Available at: www.mediuk.co.uk
- BackgroundMoffat, C., Martin, R. and Smithdale, R. (2007) Leg Ulcer Management. Oxford: Blackwell publishing
- NICE guidance relevant to study backgroundLink provided by the sponsor.
- NICE guidance relevant to study backgroundLink provided by the sponsor.
- CQUIN guidanceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymised data will be held in the University repository and be available for use in future study.
Related trials for Lower Limb Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamal Hossain, PHD study chair
School of Health Sciences,University of Southampton,Highfield Campus,University Road,Soton SO17 1BJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Ulcers, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle Brachial Pressure score (time frame: Through study completion of average of 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06557538, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.